The “progress” towards Fast-Tracking research ethics review in the NHS ethics system

Some of you may be aware that the National Research Ethics Service has been trialling a Fast-Track system for dealling rapidly with applications that present “no material ethical issues”. They have recently published a report on this trial which can be found here: Developing NRES.

The summary of the report is:

An internal  review of applications to Research Ethics Committees (RECs) and the national  queries line indicated there were many studies that carried no risk and would be no or minimal intrusion on subjects. The National Research Ethics Service (NRES) therefore funded a pilot project to explore the ethical dimensions of possible “fast track” review

Three lay members of RECs, appointed through invitation and interview, were able to draw up broad guidance on what might be seen as “Research with No Material Ethical Issues”.

35 to 40 per cent of applications to four RECs, chosen to represent the range of RECs in England, were deemed suitable for such review.

Fast track review revealed occasional variation in decisions and issues raised but none beyond what we would expect between full committees nor did it seem to jeopardise the rights dignity safety or well being of research subjects.

Based on these findings and similar review in other countries, a pilot of fast track review will be conducted in South London early 2009.

It is an interesting report and trial although there are some things to be concerned about here.  In particular it is worrisome that they didn’t seem to take variance between the fast-track process and the normal committee review as a particularly concerning problem.

3 applications that were approved by the fast-track committee were rejected by the full committee, and of the other applications the full committee made 29 comments that the fast-track committee made no equivalent comments.

The report argues that since in these cases the differences wouldn’t have jeopardised the rights dignity safety or well being of research subjects we ought not be concerned by the variance. This argument seems to miss the point of such a trial, especial such a relatively small trial.  The trial wouldn’t have been expected to show cases where the variance jeopardised the rights dignity safety or well being of research subjects, these cases will be (hopefully) rare. What instead it established is that significant variance is likely to happen, and over time it is likely that some of this variance will jeopardise the rights dignity safety or well being of research subjects.

By David Hunter

 

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